FDA UDI
In Commercial Distribution
🇺🇸 United States
PLR4955L
DI: 00606509401548
·
Model: PLR4955L
·
Pride Mobility Products Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PLR4955L
- Primary DI
- 00606509401548
- Version / Model
- PLR4955L
- Catalog Number
- N/A
- Company Name
- Pride Mobility Products Corp
- Labeler DUNS
- 041477449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-15
- Public Version
- 1
- Public Version Date
- 2023-06-23
- Public Version Status
- New
- Public Device Record Key
- 0ee5b558-bb51-4656-aab1-ef832abf432d
Device Description
An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| INO | Chair, Positioning, Electric | Physical Medicine | 890.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10796 | Stand-up chair, electric | An electrically-powered device designed to support a patient with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The electrically-powered features may include a seat that can be elevated and tilted forward to help the person stand, and/or a seat composed of several articulated sections that tilt to facilitate the person's activities and comfort. It is neither a stander (which is intended to support a patient in a prolonged standing position) nor a wheelchair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606509401548 | GS1 |